Formulation Development Laboratory

ChoroPharma, LLC has completed the setup and establishment of their first formulation development lab in Research Triangle Park, NC. This milestone allows ChoroPharma to complete drug development studies for our complex ophthalmic products. This includes all required drug substance and drug product analytical characterization including assay and related substances, particle size distribution/zeta potential, and in-vitro release testing. The testing ability of the formulation development lab will allow prototype formulation development to be completed, including formulation optimization and stability assessment.

The first four (4) product development reports, per QbD, will be completed by the end of this year. The development will include:

• Reference list product (RLD) physiochemical characterization and stability assessment

• Drug substance and excipient selection and characterization

• Drug product formulation development and stability

• Manufacturing process development and proposed manufacturing recommendations

• Identification of Critical Process Parameters (CPP)

FDA Q1/Q2 Sameness Received for Fourth Product

ChoroPharma, LLC has received FDA's response confirming Q1/Q2 sameness for our fourth ophthalmic suspension medication. Quality by design and registration batches are planned to begin Q1 2019.

ChoroPharma's Innovative Growth

ChoroPharma, LLC is a new company that will provide high quality generic ophthalmic medication to its patients. ChoroPharma is on track to begin operations soon. Troy Chavis, the founder of ChoroPharma, has obtained degrees in both Chemical Engineering and Biology, and has spent years in small molecule pharmaceutical generic manufacturing with specialization in aseptically filled products. ChoroPharma strives to deliver quality pharmaceutical products at a generic cost.

The market for generic ophthalmic suspensions is a billion dollar market in the U.S. and worldwide. ChoroPharma has recognized the high demand for these products, as well as a shortage in supply. With this strategy, we have the potential to set the stage as an influential niche company for generic ophthalmic suspensions.